Neo Gaba 300 Capsule 300 mg

Negara: Yordania

Bahasa: Inggris

Sumber: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Bahan aktif:

Pregabalin 300 mg

Tersedia dari:

الشركة المتحدة لصناعة الأدوية - United Pharmaceutical Manufacturing Co. Ltd.

Kode ATC:

N03AX16

INN (Nama Internasional):

Pregabalin 300 mg

Dosis:

300 mg

Unit dalam paket:

60

Diproduksi oleh:

UNITED PHARM.MFG.CO.LTD(UPM)/JORDAN (الاردن)

Ringkasan produk:

58.33 :سعر الجمهور + الضريبة

Selebaran informasi

TID = Three divided doses
BID = Two divided doses
* Total daily dose (mg/day) should be divided as in-
dicated by dose regimen to provide mg/dose
+ Supplementary dose is a single additional dose
USE IN PATIENTS WITH HEPATIC IMPAIRMENT
No dose adjustment is required for patients with
hepatic impairment.
PEDIATRIC POPULATION
The safety and efficacy of
NEO GABA
®
in children
below the age of 12 years and in adolescents (12-17
years of age) have not been established. No data
are available.
Use in the elderly (over 65 years of age)
Elderly patients may require a dose reduction of
pregabalin due to a decreased renal function.
METHOD OF ADMINISTRATION
NEO GABA
®
may be taken with or without food.
NEO GABA
®
is for oral use only.
CONTRAINDICATIONS:
- Hypersensitivity to the active substance or to any
of the excipients.
- Angioedema and hypersensitivity reactions have
occurred in patients receiving pregabalin therapy.
PRECAUTIONS:
Misuses abuse potential or dependence: Cases
of misuse, abuse and dependence have been re-
ported. Caution should be exercised in patients with
a history of substance abuse and the patient should
be monitored for symptoms of pregabalin misuse,
abuse or dependence (development of tolerance,
dose escalation, drug-seeking behavior have been
reported).
IMPORTANT IDENTIFIED RISKS:
- Some patients treated with pregabalin have expe-
rienced, elevated, mood (Euphoria).
- Before taking pregabalin, patients should tell their
doctor if they have a history of alcoholism or drug
dependence. Patients should let their doctor know if
they think they need more of the medicine than has
been prescribed for them.
DIABETIC PATIENTS: In accordance with current clini-
cal practice, some diabetic patients who gain weight
on pregabalin treatment may need to adjust hypo-
glycemic medicinal products.
HYPERSENSITIVITY REACTIONS: There have been re-
ports of hypersensitivity in patients shortly after ini-
tiation of treatment with
NEO GABA
®
. Adverse re-
actions included skin redness, blisters, hives, rash,
dyspnea, an